FDA Inspection 628446 — Bentley Laboratories LLC
The FDA completed an inspection of Bentley Laboratories LLC on November 17, 2009 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 17, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1222 | 21 CFR 211.67(b)(4) | Cleaning SOPs/equipment identification |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |